Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH



Status:Terminated
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:7/27/2018
Start Date:September 2016
End Date:March 2018

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Trial Summary
Trial Overview
Inclusion Criteria

Multicenter, Controlled, Randomized, Safety and Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in
the treatment of aneurysmal subarachnoid hemorrhage.


Inclusion Criteria:

1. Ruptured saccular aneurysm repaired by neurosurgical clipping

2. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified
Fischer scale

3. WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must
not require an EVD prior to aneurysm repair

Exclusion Criteria:

1. Major complication during aneurysm repair such as, but not limited to, massive
intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure
the ruptured aneurysm

2. Angiographic vasospasm prior to randomization

3. Evidence of cerebral infarction with neurological deficit
We found this trial at
4
sites
University of California at San Francisco
San Francisco, California 94143
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San Francisco, CA
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University of Maryland Medical Systems
Baltimore, Maryland 21201
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Baltimore, MD
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University of Alberta Hospital/Mackenzie Health Sciences Centre
Edmonton, Alberta
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Edmonton,
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Dignity Health, St. Joseph's Hospital & Medical Center
Phoenix, Arizona 85013
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Phoenix, AZ
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